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Abstract: FR-PO0532

Clinical Assessment of Sodium and Acid-Base Balance with the Neokidney Sorbent-Based Portable Hemodialysis Device

Session Information

Category: Dialysis

  • 802 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Ficheux, Maxence, Centre Hospitalier Universitaire de Caen Normandie, Caen, Normandy, France
  • Bolhuis, Dian Petra, Universitair Medisch Centrum Utrecht, Utrecht, UT, Netherlands
  • Conan, Christophe, Nextkidney BV, Bussum, NH, Netherlands
  • Bluechel, Christian, Nextkidney BV, Bussum, NH, Netherlands
  • Gerritsen, Karin G., Universitair Medisch Centrum Utrecht, Utrecht, UT, Netherlands
Background

The Neokidney is a compact (13 kg), portable device developed for Short Frequent Hemodialysis (SFHD). It uses a sorbent-based system to regenerate dialysate, requiring only 4.5 L of fluid. In contrast to older systems such as REDY, which struggled with sodium control, Neokidney aims to provide precise isonatraemic dialysis. This report analyses sodium and acid-base balance during Neokidney therapies conducted as part of a safety and efficacy study at the Caen University

Methods

This prospective, single-arm, first-in-human trial was conducted between March and June, 2024. Four adult SFHD patients received 4–8 Neokidney sessions over a 3-week period, with exposure gradually increased to up to 5 consecutive sessions per week. Two baseline sessions using standard SFHD machine were included. Blood samples were collected pre- and post-dialysis; dialysate samples were taken at defined intervals.

Results

A total of 25 Neokidney treatments were performed without device-related serious adverse events. Dialysate sodium concentrations adapted to plasma levels within 30 minutes and remained stable, providing consistent isonatremic dialysis. Plasma sodium stayed approximately unchanged during sessions (median [Q1–Q3] change: −1.0 [−2.0–0] mmol/L with Neokidney vs. +1.5 [1.0–2.3] mmol/L at baseline). No cumulative effects were seen across sessions; pre-dialysis sodium levels remained stable.
The dialysate buffer concentration (bicarbonate + lactate) stabilized within 30 minutes at levels correlating to the patient’s pre-dialysis plasma concentration. Plasma buffer concentrations during Neokidney sessions slightly reduced (-2.7 [-4.0–-1.2] mmol/L) vs. a rise during baseline (+7.1 [6.5–8.0] mmol/L). Plasma pH was stable or slightly increased (0.02 [-0.01–0.04]) during Neokidney and baseline (0.01 [-0.01–0.04]). While acid-base balance remained approx. unchanged per session, a slight downward trend in pre-dialysis buffer and pH was noted over repeated treatments.

Conclusion

Neokidney showed promise as a safe, effective SFHD system.. Dialysate sodium remained stable throughout all therapies. Acid-base data suggest buffer supply was insufficient to correct patient’s underlying metabolic acidosis across multiple sessions. This will be addressed by increasing dialysate buffer via partial chloride–lactate replacement.

Digital Object Identifier (DOI)